The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on sarcomas. These studies are focusing on anticancer vaccines, T-cell therapy, combination chemotherapy, pathway inhibitors, preoperative radiotherapy, and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: Vaccination to Enhance the Antitumor Activity of GD2 Chimeric Antigen Receptor-Expressing, Varicella-Zoster Virus–Specific T Cells in Subjects With Advanced Sarcomas (VEGAS)
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Baylor College of Medicine, National Cancer Institute, Center for Cell and Gene Therapy (Baylor College of Medicine), The Methodist Hospital System, Texas Children’s Hospital
Purpose: To find the largest safe dose of GD2 T cells (also called iC9-GD2-CAR-VZV-CTLs) and evaluate whether a Varicella-Zoster virus vaccine can improve the expansion and persistence of infused T cells
Primary Outcome Measures: Number of subjects with a dose-limiting toxicity [time frame: 6 weeks]
Principal Investigator: Lisa L. Wang, MD; (832) 824-4822, llwang@texaschildrens.org
ClinicalTrials.gov Identifier: NCT01953900
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Study Title: A Phase I Trial of Pomalidomide in Combination With Liposomal Doxorubicin in Patients With Advanced or Refractory Kaposi Sarcoma
Study Type: Phase I/interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To test a combination of the anticancer drugs pomalidomide (CC-4047) and liposomal doxorubicin in patients with Kaposi sarcoma
Primary Outcome Measures: Safety/tolerability of dose combinations [time frame: 3 months]; pharmacokinetics of combination therapy [time frame: first 3 days of cycle]
Principal Investigator: Thomas S. Uldrick, MD; contact Anaida Widell, (301) 451-3694, awidell@cc.nih.gov
ClinicalTrials.gov Identifier: NCT02659930
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Study Title: A Phase Ib Study: Treatment of Refractory Pancreatic Adenocarcinoma and Advanced Soft-Tissue or Bone Sarcomas Using Decitabine Combined With Gemcitabine
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Holden Comprehensive Cancer Center (University of Iowa)
Purpose: To assess the safety and maximum tolerated dose of decitabine in combination with gemcitabine among previously treated patients diagnosed with advanced pancreatic adenocarcinoma or sarcoma (soft tissue and bone)
Primary Outcome Measures: Dose-limiting toxicity [time frame: up to 30 days after the last date of any study therapy]; tumor response rate—change at evaluations [time frame: change on two consecutive evaluations at least 8 weeks apart up to 30 days after the last date of any study therapy]
Principal Investigator: Laith Abushahin, MD; (319) 356-7407, laith-abushahin@uiowa.edu
ClinicalTrials.gov Identifier: NCT02959164
PHASE II
Study Title: Phase II Study of TAK-228 (MLN0128) in Soft-Tissue Sarcomas With Dysregulation of the mTOR Pathway
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Fox Chase Cancer Center
Purpose: To test the efficacy of TAK-228 for patients ≥ 18 years of age with complex genomic sarcomas exhibiting phosphoinositide-3 kinase (PI3K) pathway dysregulation
Primary Outcome Measures: The progression-free survival rate with TAK-228 in sarcoma patients with PI3K/AKT/mTOR pathway dysregulation [time frame: 12 weeks posttreatment]
Principal Investigator: Sujana Movva, MD; (888) 369-2427, sujana.movva@fccc.edu
ClinicalTrials.gov Identifier: NCT02987959
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Study Title: Pilot Study Evaluating Hypofractionated Preoperative Radiation Therapy for Soft-Tissue Sarcomas of the Extremity and Chest Wall
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Medical College of Wisconsin
Purpose: To determine local control and overall/progression-free survival using hypofractionated preoperative radiation therapy in patients with primary localized soft-tissue sarcomas
Primary Outcome Measures: Local control [time frame: 5 years]
Principal Investigator: Meena Bedi, MD; (414) 805-4400, mbedi@mcw.edu
ClinicalTrials.gov Identifier: NCT02634710
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Study Title: Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft-Part -Sarcoma
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To determine whether cediranib, which blocks the creation of new blood vessels, is effective in inhibiting tumor growth in individuals who have alveolar soft-part sarcoma
Primary Outcome Measures: To determine whether pediatric patients with aleveolar soft-part sarcoma will experience at least a minimal response rate when treated with AZD2171 [time frame: 2 cycles]
Principal Investigator: Alice P. Chen, MD; (301) 496-4291, chenali@mail.nih.gov
ClinicalTrials.gov Identifier: NCT00942877
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Study Title: A Phase II Trial of Preoperative Proton Therapy in Soft-Tissue Sarcomas of the Extremities and Body Wall
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Loma Linda University
Purpose: To determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies
Primary Outcome Measures: Late radiation toxicities (> grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness) [time frame: at 2 years from the start of radiation treatment]
Principal Investigator: Gary Yang, MD, Loma Linda University Medical Center; (909) 558-4000 ext 44280, gyang@llu.edu
ClinicalTrials.gov Identifier: NCT01819831
OBSERVATIONAL
Study Title: Transcutaneous Oxygen as a Predictor of Wound Healing Complications in Preoperatively Radiated Soft Tissue Sarcoma
Study Type: Observational
Study Sponsor and Collaborators: Loyola University; see others at clinicaltrials.gov
Purpose: To evaluate the relationship between preoperative skin oxygenation and wound outcomes after sarcoma resection in a multicenter prospective analysis
Primary Outcome Measures: Wound healing [time frame: 120 days]
Principal Investigator: Lukas M. Nystrom, MD, Loyola University; (708) 216-1274, lnystrom@lumc.edu
ClinicalTrials.gov Identifier: NCT02897128
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
